ustekinumab-srlf

FDA Drug Profile — IMULDOSA

ustekinumab-srlf is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand name including IMULDOSA. Available dosage form: injection.

Drug Details

Generic Name
ustekinumab-srlf
Brand Names
IMULDOSA
Application Number
BLA761364
Sponsor
Accord BioPharma Inc.
NDC Codes
3
Dosage Forms
INJECTION
Routes
INTRAVENOUS, SUBCUTANEOUS
Active Ingredients
USTEKINUMAB-SRLF

Indications and Usage

1 INDICATIONS AND USAGE IMULDOSA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. (1.1) active psoriatic arthritis in adult and pediatric patients 6 years of age and older. (1.2) moderately to severely active Crohn’s disease in adult patients. (1.3) moderately to severely active ulcerative colitis in adult patients. (1.4) 1.1 Plaque Psoriasis (PsO) IMULDOSA is indicated for the treatment of adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. 1.2 Psoriatic Arthritis (PsA) IMULDOSA is indicated for the treatment of adults and pediatric patients 6 years of age and older with active psoriatic arthritis. 1.3 Crohn’s Disease (CD) IMULDOSA is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease. 1.4 Ulcerative Colitis (UC) IMULDOSA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.